Hawaii Specialty Pharmacy can support and manage a REMS program aligned with the goals of the manufacturer. We offer:

• Project management responsible for the internal cross function for the program
• Identification of multiple REMS strategies which anticipate all potential scenarios, including FDA responses
• Leveraging of efficiencies to maximize performance and mitigate costs
• Anticipation of future needs and plan for scalability
• Timely reporting of information to manufacturer
• Ongoing analysis of program effectiveness and needs for improvement
• Preparation for auditing
• Hawaii Specialty Pharmacy has experience managing REMS programs across multiple disease states, including programs ranging from medication guides to ones requiring Elements to Assure Safe Use (ETASU).